MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-16 for SENTINELLE ARRAY BREAST COIL SENTINELLE VANGUARD BREAST COIL manufactured by Sintinelle Vanguard.
[36623910]
Siemens magnetom espree 1. 5t mri scanner with the sentinelle vanguard breast coil; (for siemens breast mri auxiliary table with 2/4/8- channel coil array breast coil) was utilized on patient for mri of the breast. The patient reported right sided burning of the right flank region immediately after the mri exam. Upon assessment by the technologist, redness was observed in the reported area by the patient. The next day, the patient was evaluated and treated by her physician for blistering on right side of her abdomen and her right forearm. Contributing factors; rf power was being transmitted by the body coil; and the transmitted rf power was being transmitted to a volume/anatomy that did include the abdomen and forearm. Suspect patient's forearm and abdomen were touching, (and right at the level of the thermal injury), during the examination. The electrical conductivity of possible perspiration might well have been related to the observed outcome. There were no unusual factors noted, no excessive sweating was observed. The coil was removed from service and will be sent back to manufacturer for failure mode testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059480 |
| MDR Report Key | 5383821 |
| Date Received | 2016-01-16 |
| Date of Report | 2016-01-16 |
| Date of Event | 2016-01-04 |
| Date Added to Maude | 2016-01-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SENTINELLE ARRAY BREAST COIL |
| Generic Name | SENTINELLE ARRAY BREAST COIL |
| Product Code | MOS |
| Date Received | 2016-01-16 |
| Model Number | SENTINELLE VANGUARD BREAST COIL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SINTINELLE VANGUARD |
| Manufacturer Address | LANCASTER PA 17601 US 17601 |
| Brand Name | SIEMENS MAGNETOM ESPREE 1/5T |
| Generic Name | MRI SCANNER |
| Product Code | LNH |
| Date Received | 2016-01-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-16 |